LYON, France, 27th February 2008 – Sanofi Pasteur MSD
welcomes the decision by the health authorities in Sweden to
recommend free vaccination of girls in school to protect them
against cervical cancer and other human papillomavirus
(HPV)-related genital diseases.
“This is great news for the girls in Sweden," comments Didier
Hoch, president of Sanofi Pasteur MSD. "We hope that vaccination
programmes will be implemented quickly, so girls women could soon
have full access to these programmes that will help save lives and
protect girls' and women's health from cervical cancer and other
HPV-related genital diseases."

Yesterday, the Swedish National Board of Health and Welfare
(Socialstyrelsen) recommended universal free vaccination of girls
in school years five and six (aged 10-12 years) through the school
health service. According to the administrative procedure in
Sweden, this recommendation is now open for referral with final
confirmation expected in April 2008 and implementation at county
level from autumn 2008.

In May 2007, the Pharmaceutical Benefits Board in Sweden had
included Gardasil® in the national Pharmaceutical Benefits
Scheme for girls aged 13-17 years, marking the first time that the
Board granted a vaccine reimbursement status. The
reimbursement enables catch up vaccination of girls aged 13-17
years in addition to the now recommended free routine vaccination
girls aged 12 at school.

Thirteen Western European countries (Austria, Belgium, Denmark,
France, Germany, Greece, Italy, Luxemburg, Norway, Portugal, Spain,
Switzerland, and the United Kingdom) have already recommended
routine human papillomavirus vaccination for pre-adolescents girls,
often coupled with catch-up programmes for adolescent girls and
young women. Similar recommendations were made in the United
States, Canada and Australia

In eleven of these countries (Belgium, Denmark, France, Germany,
Greece, Italy, Luxemburg, Portugal, Spain, Switzerland, and the
United Kingdom), reimbursement or funding is already in place or
has been announced for 2008.
Gardasil® is a quadrivalent (6,11,16,18) HPV vaccine that can
help prevent cervical cancer and other HPV-related genital
diseases, including precancerous cervical and vulvar lesions and
genital warts caused by the virus types targeted by the
vaccine.
Gardasil® has been approved in 93 countries worldwide and has
met with great recognition from experts, health authorities and
physicians. More than 20 million doses were distributed worldwide
until the end of December 2007.

* * *

Notes to editors
The burden of cervical cancer and other human papillomavirus
diseases
Despite screening for early detection, cervical cancer remains the
second most common cause of death from cancer (after breast cancer)
among young women (15-44 years) in Europe . Around 33,500
women are diagnosed with, and 15,000 women die from cervical cancer
each year.
In addition, hundreds of thousands of women are diagnosed with
other HPV-related genital diseases that start before the occurrence
of cervical cancer and can touch other genital organs than the
cervix. These diseases include pre-cancerous and early cervical
lesions , , , vulvar and vaginal cancer , , , pre-cancerous vulvar
and vaginal lesions , , , and genital warts.
Early cervical lesions and genital warts in particular can occur
much faster than cervical cancer, often within a few months after
exposure to the virus.
It is estimated that types 6/11/16/18 cause 75% of cervical cancer
in Europe (types 16/18), 70% of vulvar and vaginal cancers,
70% of pre-cancerous(CIN2/3) and 35-50% of early cervical lesions
(CIN1), 70% of pre-cancerous vulvar and vaginal lesions, and 90% of
genital warts. ,
Virus types 6/11 cause 10% of early cervical lesions (~80,000 cases
each year) in Europe in addition to the 25% of early cervical
lesions caused by types 16 and 18 (~200,000)32, , , Virus
types 6 /11 also cause 90% of genital warts (~225,000
cases)29,30,32, ,
Though type 6/11-related early cervical lesions usually do not
progress to cancer, screening cannot distinguish them from type
16/18-related which may progress to cancer. They require the same
follow up and may lead to the same anxiety in women.
Genital warts can cause anxiety which may impact personal
relationships. Even if effective in the short term, physically
ablative therapies are painful and recurrence rates can be high, as
only the visible lesion is excised while the infection persists. ,
,

Current EU indication of Gardasil®
Gardasil®, human papillomavirus vaccine [types 6,11,16,18]
(recombinant, adsorbed), can be given to children and adolescents 9
to15 years and adult females 16 to 26 years of age and is indicated
for the prevention of cervical carcinoma (cervical cancer), high
grade cervical dysplasia CIN2/3 (precancerous cervical lesions),
high grade vulvar dysplastic lesions VIN 2/3 (precancerous vulvar
lesions) and external genital warts (condyloma acuminata) caused by
human papillomavirus types 6, 11, 16 and 18.

About Sanofi Pasteur MSD
Sanofi Pasteur MSD is a joint venture between sanofi pasteur, the
vaccine division of sanofi-aventis, and Merck & Co., Inc.
Combining innovation and expertise, Sanofi Pasteur MSD is the only
company in Europe dedicated exclusively to vaccines. Sanofi Pasteur
MSD is able to draw on the research expertise of sanofi pasteur and
Merck & Co., Inc., together with their teams throughout the
world, to focus on the development of new vaccines for Europe,
which aim to extend protection to other diseases and perfect
existing vaccines in order to improve the acceptability, efficacy
and tolerability of vaccination.